MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-03 for SPECTRUM IQ 3570009 manufactured by Baxter Healthcare Corporation.
[122511565]
Transfusion of 1 unit of rbcs was ordered. Rn began transfusion at 100 ml/hr. During transfusion rn noted that blood bag did not appear to be draining at normal rate. Rn checked clamps, iv site/iv patency, reviewed pump settings and increased rate to 125 ml/hr. Rn continued to monitor transfusion and blood bag still appeared to be draining very slow, patient received approximately 10-20 mls in 2 hours. Normal saline bag was clamped, but level also appeared lower then normal. Rn called a second rn to room to access/evaluate equipment. Rn again checked equipment and notified blood bank and doctor. Per blood bank, rn disposed of blood and new transfusion order placed by doctor. New iv pump obtained and new transfusion started without any issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7929570 |
| MDR Report Key | 7929570 |
| Date Received | 2018-10-03 |
| Date of Report | 2018-09-20 |
| Date of Event | 2018-09-16 |
| Report Date | 2018-09-20 |
| Date Reported to FDA | 2018-09-20 |
| Date Reported to Mfgr | 2018-10-03 |
| Date Added to Maude | 2018-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRUM IQ |
| Generic Name | INFUSION SAFETY MANAGEMENT SOFTWARE |
| Product Code | PHC |
| Date Received | 2018-10-03 |
| Model Number | 3570009 |
| Catalog Number | 3570009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | 711 PARK AVE. MEDINA NY 14103 US 14103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-03 |